TriangleNCT00306202 · OUTCOME
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng.h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
What was measured
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Analysis population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
Groups in this outcome
Dasatinib 60 mg/m^2
Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Dasatinib 80 mg/m^2
Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Dasatinib 100 mg/m^2
Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
Dasatinib 120 mg/m^2
Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Dasatinib 60 mg/m^2 | 18 |
| Dasatinib 80 mg/m^2 | 20 |
| Dasatinib 100 mg/m^2 | 15 |
| Dasatinib 120 mg/m^2 | 8 |
Reported measurements
Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 0 | 0 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 0 | 0 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 127.7 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated. |
| Dasatinib 120 mg/m^2 | 142.1 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated. |
Children (age>=2 & <12yr; n=10; n=14; n=7; n=5)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 313.9 | 59.8 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 513.6 | 99.2 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 429.1 | 76.8 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 817.6 | 93.7 | Not reported | Not reported | Not reported |
Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 305.8 | 60.9 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 605.1 | 25.3 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 1008.9 | 69.4 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 547.8 | 58.2 | Not reported | Not reported | Not reported |
Above 18 years (n=0; n=1; n=0; n=0)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 0 | 0 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 390.0 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated. |
| Dasatinib 100 mg/m^2 | 0 | 0 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 0 | 0 | Not reported | Not reported | Not reported |
Total
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 310.3 | 58.6 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 527.8 | 90.4 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 589.8 | 86.2 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 594.4 | 101.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 0
- group Id
- OG001
- spread
- 0
- value
- 0
- comment
- Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
- group Id
- OG002
- spread
- NA
- value
- 127.7
- comment
- Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
- group Id
- OG003
- spread
- NA
- value
- 142.1
- title
- Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)
- categories
- measurements
- group Id
- OG000
- spread
- 59.8
- value
- 313.9
- group Id
- OG001
- spread
- 99.2
- value
- 513.6
- group Id
- OG002
- spread
- 76.8
- value
- 429.1
- group Id
- OG003
- spread
- 93.7
- value
- 817.6
- title
- Children (age>=2 & <12yr; n=10; n=14; n=7; n=5)
- categories
- measurements
- group Id
- OG000
- spread
- 60.9
- value
- 305.8
- group Id
- OG001
- spread
- 25.3
- value
- 605.1
- group Id
- OG002
- spread
- 69.4
- value
- 1008.9
- group Id
- OG003
- spread
- 58.2
- value
- 547.8
- title
- Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2)
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 0
- comment
- Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
- group Id
- OG001
- spread
- NA
- value
- 390.0
- group Id
- OG002
- spread
- 0
- value
- 0
- group Id
- OG003
- spread
- 0
- value
- 0
- title
- Above 18 years (n=0; n=1; n=0; n=0)
- categories
- measurements
- group Id
- OG000
- spread
- 58.6
- value
- 310.3
- group Id
- OG001
- spread
- 90.4
- value
- 527.8
- group Id
- OG002
- spread
- 86.2
- value
- 589.8
- group Id
- OG003
- spread
- 101.5
- value
- 594.4
- title
- Total
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 8
- units
- Participants
- description
- PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Dasatinib 60 mg/m^2
- description
- Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG001
- title
- Dasatinib 80 mg/m^2
- description
- Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG002
- title
- Dasatinib 100 mg/m^2
- description
- Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG003
- title
- Dasatinib 120 mg/m^2
- param Type
- GEOMETRIC_MEAN
- population Description
- All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
- reporting Status
- POSTED
- time Frame
- During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
- title
- Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group
- type
- SECONDARY
- unit Of Measure
- ng.h/mL
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Preserved source evidence · Not medical advice